Model Number 72081-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Skin Infection (4544); Swelling/ Edema (4577)
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Event Date 12/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dhrs (device history record) for the freestyle libre sensor kit were reviewed, and the dhrs showed the freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.If the product is returned, a physical investigation will be performed and a follow-up report submitted.It is unknown if the user was using android, ios, or a fs libre reader with the fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer experienced a skin reaction while wearing an adc device and experienced symptoms described as itching and swelling at the puncture site.Customer had contact with a healthcare professional and received prescribed cortisone ointment for treatment.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer experienced a skin reaction while wearing an adc device and experienced symptoms described as itching and swelling at the puncture site.Customer had contact with a healthcare professional and received prescribed cortisone ointment for treatment.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Additional information: section d4 (serial number) was updated from (b)(6)to (b)(6)based on returned product.Sensor (b)(6)was returned and investigated.No physical damage was observed on the sensor patch, and no issues were observed with the adhesive.No malfunction or product deficiency was identified.Therefore, this issue is not confirmed.An extended investigation was also performed on the returned sensor and determined no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor kit were reviewed and indicated that the libre sensor kit passed all tests before release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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